STATISTICAL OPTIMIZATION AND ASSESSMENT OF DIVALPROEX SODIUM EXTENDED RELEASE TABLET

Abstract

The purpose of the current experimental research was to optimize the quantities of macromolecules such as Eudragit L/100-55 and HPMC-K-100M for the development of extended release tablets of divalproex sodium, an anti-convulsant or epileptic agent used in the effective management of bipolar disorders, mania, seizures, convulsions, tremors/epilepsy. Divalproex sodium ER tablets were formulated with the help of Eudragit L/100-55 and HPMC-K-100M in variable compositions and variable amounts as per 32 factorial design technique. Tablets were prepared by direct compression technique. Quantities of polymers required for exhibiting extended release of active agent from the tablet were chosen as independent variables, in similar manner time required for drug release was chosen as dependent variable (t10%, t50%, t75%, t90%). Nine formulations were created in accordance with the plan, formulated, and tested for quality control criteria. It is obvious from the data that all formulations exceed the compendial restrictions. Kinetic parameters were established, and the data from the dissolution investigation suited kinetic models very well. For the responses, polynomial equations were created and validated. The optimum formulation of SOD5, which contains 31.25 mg of Eudragit L/100-55 & 31.25 mg of HPMCK-100M, exhibits resemblance to the commercial product of f2=85.91 and f1=2.25 (DIVALEX). SOD5 is made in a zero-order fashion, and the mechanism of drug release was found to be non - Fickian in nature (n = 0.645)